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Diagnostic Device

MMG vs EMG for Cortical Breach Detection in Low Back Pain

N/A
Waitlist Available
Led By H. Francis Farhadi, MD, PhD
Research Sponsored by H. Francis Farhadi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Unresponsive to conservative care for a minimum of 6 months
Scheduled to undergo a one-, two-, or three-level posterolateral spinal fusion surgery using Depuy Synthes Expedium pedicle screw instrumentation
Must not have
Active local or systemic infection
Osteoporosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks and 3 months after surgery
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare the accuracy of MMG vs EMG in preventing cortical bone breaches during lower back surgery.

Who is the study for?
This trial is for adults over 18 who need lower back surgery with Expedium pedicle screw instrumentation, have not improved after 6 months of non-surgical care, and can fully participate in the study. It's not for those with open wounds near the surgery site, severe obesity (BMI >45), ongoing legal cases or Workers Compensation for neck/back pain, medications affecting healing, osteoporosis, infections, metal sensitivity/pacemakers, or other serious health issues.
What is being tested?
The study compares mechanomyography (MMG) and electromyography (EMG), both FDA-approved nerve detection devices used during lower back surgeries to prevent nerve damage from screw placement. The goal is to see which method is more accurate at locating nerves to avoid cortical bone breaches.
What are the potential side effects?
Since MMG and EMG are monitoring devices rather than treatments or drugs, they don't have typical side effects. However, there may be risks associated with their use during surgery such as discomfort at the sensor sites or inaccurate readings leading to potential nerve damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My condition hasn't improved after 6 months of standard treatment.
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I am scheduled for a spinal fusion surgery using specific Depuy Synthes screws.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I currently have an infection.
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I have been diagnosed with osteoporosis.
Select...
My BMI is over 45, classifying me as morbidly obese.
Select...
I have an open wound near the surgery area or have rapid joint disease, bone loss, or osteoporosis.
Select...
I need medications that could affect the healing of my bones or soft tissues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks and 3 months after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks and 3 months after surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Success of Pedicle Screw Trajectories
Secondary study objectives
Change in the Numeric Rating Scale (NRS) Questionnaire for pain.
Change in the Oswestry Disability Index version 2.1A
Change in the PROMIS Global-10
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Intraoperative MMG vs EMG for cortical breach detectionExperimental Treatment2 Interventions
Participants in this arm will be assessed with both MMG and EMG during their lower spine fusion surgery.

Find a Location

Who is running the clinical trial?

H. Francis FarhadiLead Sponsor
3 Previous Clinical Trials
340 Total Patients Enrolled
DePuy SynthesIndustry Sponsor
32 Previous Clinical Trials
4,847 Total Patients Enrolled
H. Francis Farhadi, MD, PhDPrincipal InvestigatorUniversity of Kentucky
4 Previous Clinical Trials
1,317 Total Patients Enrolled

Media Library

Mechanomyography (Diagnostic Device) Clinical Trial Eligibility Overview. Trial Name: NCT05352048 — N/A
Lower Back Pain Research Study Groups: Intraoperative MMG vs EMG for cortical breach detection
Lower Back Pain Clinical Trial 2023: Mechanomyography Highlights & Side Effects. Trial Name: NCT05352048 — N/A
Mechanomyography (Diagnostic Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05352048 — N/A
~4 spots leftby Mar 2025
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